ISO 9001 Clause 8.3 & 8.6

[Karenlb1970]

Client provides fertility services but they can't always guarantee they will be successful of course. But they ensure the service, the information patients are provided with, the tests they receive, and the way people are treated is consistent.
But how to tackle Clause 8.3 and 8.6 in this situation?

 

[Tagin]

My view is that I would not conflate successful delivery of services with assurance of successful fertility.

- Successful delivery of services would be addressed in clause 8
- Assurance of successful fertility would be address in clause 9 (notably: Customer Satisfaction)
- Improving assurance of successful fertility would be address in clause 10

 

[Big Jim]

Client provides fertility services but they can't always guarantee they will be successful of course. But they ensure the service, the information patients are provided with, the tests they receive, and the way people are treated is consistent.
But how to tackle Clause 8.3 and 8.6 in this situation?

Interesting business concepts. I would think the 8.3 would be excludable as you are not designing anything. You are not trying to alter genetics. You are not even promising fertility.

I would think that confirming that the service provided was what was promised would be covered with 8.6.

 

[AMIT BALLAL]

@Karenlb1970, whether or not the services are effective all the time, the services can still be designed. If the services are delivered in a certain way only then the effectiveness can be achieved (at a certain level). For service design purposes, you can determine what needs to be done & how to meet the requirements of 8.3.

Determine criteria for those services at various levels, let's say samples to be tested within a maximum of 3 hours, etc.
That way the requirement of 8.6 can be met.